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Wired News – SteadyMed Reported FDA Agreed Pathway to Trevyent NDA Resubmission

Stock Monitor: Evoke Pharma Post Earnings Reporting

LONDON, UK / ACCESSWIRE / December 11, 2017 / Active-Investors issued a free report on SteadyMed Ltd (NASDAQ: STDY), which is readily accessible upon registration at www.active-investors.com/registration-sg/?symbol=STDY as the Company's latest news hit the wire. On December 08, 2017, the Company declared that the US Food and Drug Administration (FDA) will not require the Company to conduct any additional clinical trials to support its New Drug Application (NDA) resubmission for Trevyent for the treatment of pulmonary arterial hypertension (PAH). Sign up now for our free research reports at:


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SteadyMed to Repeat in-vitro Design Verification (DV) testing on Final Trevyent Product

FDA has agreed that the Company will have to repeat in-vitro Design Verification (DV) testing on the final to-be-marketed Trevyent product, supported by pharmacokinetic modelling and process validation. The application will be made under the 505(b)(2) NDA. The purpose of in-vitro DV testing is to confirm that Trevyent performance meets its design specifications.

NDA Submission and Acceptance Likely to Occur Before End of 2018

SteadyMed has begun the pre-DV activities, which precede the DV testing, with Trevyent performance data being available around mid-2018. The Company expects both NDA submission and acceptance to occur before the end of 2018. SteadyMed ended Q3 2017 with a strong cash position of approximately $37.4 million, which is believed to provide sufficient capital to fund operations through the NDA resubmission and acceptance.

SteadyMed's NDA for Trevyent to Treat PAH was Refused by FDA

On August 31, 2017, SteadyMed received a Refusal to File letter from FDA relating to its NDA for Trevyent for the treatment of PAH. Based on a preliminary review of the NDA submitted in June 2017, FDA determined that the application was not sufficiently complete to permit a substantive review. FDA requested further information on certain device specifications and performance testing and requested additional design verification and validation testing on the final, to-be-marketed Trevyent product.

Actelion's TRACLEER is the First FDA-approved Medicine for Pediatric PAH Patients in the US

In September 2017, FDA approved a new 32 mg tablet for oral suspension for Actelion Pharmaceuticals' TRACLEER® (bosentan) for use in pediatric patients aged three years and older with idiopathic or congenital PAH, to improve pulmonary vascular resistance, which is expected to result in an improvement in exercise ability. With this approval, TRACLEER became the first FDA-approved medicine for pediatric PAH patients in the United States. Actelion Pharmaceuticals is one of the Janssen Pharmaceutical Cos. of Johnson & Johnson.

What is Pulmonary Arterial Hypertension?

PAH is a life-threatening disease caused due to high blood pressure in the lungs. In PAH, increased pressure in the vessels is caused by obstruction in the small arteries in the lung, for a variety of reasons, including drug-related cause, HIV infection, connective tissue/autoimmune disorders and others. There is no cure for PAH, and it worsens over time. The most common symptoms associated with PAH include breathlessness, fatigue, weakness, angina, syncope, and abdominal distension.

About Trevyent

Treprostinil delivered via the PatchPump technology is branded by SteadyMed as Trevyent. Treprostinil is the only parenteral treatment for PAH that is approved by the FDA for both intravenous and subcutaneous administration. Trevyent is a small, discreet, single-use (2-day) PatchPump, pre-filled with treprostinil and pre-programed at the correct delivery rate. PatchPump is equipped with sensors to provide patients audible and visual feedback on successful delivery and end of dosing.

SteadyMed intends to commercialize Trevyent in the US and has signed an exclusive license and supply agreement with Cardiome Pharma Corp. for the commercialization of Trevyent in Europe, Canada, and the Middle-East, pending regulatory approvals.

Stock Performance Snapshot

December 08, 2017 - At Friday's closing bell, SteadyMed's stock rallied 13.23%, ending the trading session at $3.51.

Volume traded for the day: 2.26 million shares, which was above the 3-month average volume of 41.79 thousand shares.

Stock performance in the last month – up 3.24%; past twelve-month period – up 15.08%; and year-to-date - up 35.00%

After last Friday's close, SteadyMed's market cap was at $88.66 million.

The stock is part of the Healthcare sector, categorized under the Drugs - Generic industry. This sector was up 1.2% at the end of the session.


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